GXP Solutions | Newsletter

How to Audit a RABS (Restricted Access Barrier Systems) isolators for GMP

How to Audit a RABS (Restricted Access Barrier Systems) isolators for GMP (Good Manufacturing Practices) involves thorough assessment to ensure compliance with regulatory requirements and industry standards. Here’s a structured approach you can follow: Pre-Audit Preparation Review Documentation: Obtain and review relevant SOPs (Standard Operating Procedures), validation documents, maintenance records, and any previous audit reports […]

June 16, 2024

What are the Adverse Event Reporting Requirements Based on Good Pharmacovigilance Practices (GVP) Module VI

In Good Pharmacovigilance Practices (GVP) Module VI, adverse event reporting is a crucial aspect of ensuring the safety of medicinal products. Here’s an overview of adverse event reporting based on GVP Module VI: 1. Definition of Adverse Event (AE) and Serious Adverse Event (SAE): GVP Module VI typically provides definitions for adverse events and serious […]

April 15, 2024

ICH E2B(R3) Electronic Transmission of Individual Case Safety Reports Implementation Guide – Explained

ICH E2B(R3) is a guideline developed by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). This guideline is focused on the standardization of the format, content, and structure of individual case safety reports (ICSRs) for the electronic transmission of safety information for medicinal products, particularly for adverse events (AEs) […]

April 3, 2024

How to Perform Clinical Trial Source Data Verification (SDV)

Performing Source Data Verification (SDV) in a clinical trial involves comparing the data recorded on the Case Report Form (CRF) or electronic equivalent (e.g., eCRF) with the original source documents to ensure accuracy, reliability, and compliance with regulatory requirements. The aim of SDV is to look for three (3) things: Data errors Procedural errors Fraud […]

March 21, 2024